Prospective Study on Patients With Obstructive Sleep Apnea in Hong Kong (PrOSA)

Recruiting

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT04659291
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Obstructive sleep apnea syndrome (OSAS) is a common disorder with prevalence rates of at least 4% among the middle-aged male Caucasians and Hong Kong (HK) Chinese populations. It is characterized by repetitive episodes of upper airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor health status. OSAS patients are at increased risks of non-fatal and fatal cardiovascular morbidity and mortality including sudden death, in addition to being more prone to road traffic accidents. However, there is no long term follow up of patients with OSAS on the incidence of cardiovascular disease, compliance on the therapy and the impact of the quality of life. The study is aimed to carry out a prospective observational study assessing the role of OSAS as a possible cause of increased cardiovascular risk and cognitive decline.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-30
• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20
• Primary Completion: 2028-08-29
• Study Completion: 2028-08-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• suspected obstructive sleep apnea syndrome
• aged 18 or above
• must be able to speak, read and understand Chinese or English
• possess the ability to respond to questions and follow instructions.

Exclusion Criteria

• already treated sleep apnea,
• a limited life expectancy due to illness unrelated to sleep apnea
• human immunodeficiency virus (HIV),
• advanced renal disease,
• uncontrolled malignancies
• documented alcohol or drug abuse up to 1 year prior to inclusion in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of Cardiovascular disease	5 years

Secondary Outcome Measures

Name	Time	Method
Change of Epworth Sleepiness Score	5 years	The Epworth Sleepiness Scale can be used to assess daytime sleepiness. The scores range between 0 and 24. Higher scores mean more sleepiness.
Change of Montreal Cognitive Assessment score (MoCA)	5 years	MoCA scores range between 0 and 30. Higher scores mean a better cognitive function.

Trial Locations

Locations (1)

Chinese University of Hong; 🇭🇰 Hong Kong, Please Select, Hong Kong